MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. DIAGNOSTIC EP CATHETER FJ, 7F; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Deflective mechanism not working on reprocessed cs (coronary sinus) catheter, removed from body and a new catheter inserted.

• Brand Name: DIAGNOSTIC EP CATHETER FJ, 7F
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 11768754
• Report Number: 11768754
• Device Sequence Number: 3998919
• Product Code: NLH
• UDI-Device Identifier: 00885825000288
• UDI-Public: (01)00885825000288(17)230331(10)4462063
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/30/2021
• Report Date (Section F): 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: BD710FJ282RTS
• Device Lot Number: 4462063
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 103
• Date Report Sent to FDA: 04/30/2021